MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-06 for NEO-FIT NEONATAL ENDOTRAC 42-2540 manufactured by Coopersurgical, Inc..
[137014773]
Coopersurgical, inc. Is currently investigating the reported complaint condition. Once the investigation is completed a follow up report will be filed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[137014774]
(b)(4). Ett slid in 2cm- velcro falling off neofit.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1216677-2019-00030 |
MDR Report Key | 8309983 |
Date Received | 2019-02-06 |
Date of Report | 2019-02-05 |
Date of Event | 2019-01-23 |
Date Mfgr Received | 2019-01-25 |
Device Manufacturer Date | 2018-10-26 |
Date Added to Maude | 2019-02-06 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | MR. PETER NIZIOLEK |
Manufacturer Street | 50 CORPORATE DRIVE |
Manufacturer City | TRUMBULL CT 06611 |
Manufacturer Country | US |
Manufacturer Postal | 06611 |
Manufacturer Phone | 2036015200 |
Manufacturer G1 | COOPERSURGICAL, INC, |
Manufacturer Street | 75 CORPORATE DRIVE |
Manufacturer City | TRUMBULL CT 06611 |
Manufacturer Country | US |
Manufacturer Postal Code | 06611 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 0 |
Brand Name | NEO-FIT NEONATAL ENDOTRAC |
Generic Name | NEO-FIT |
Product Code | JAY |
Date Received | 2019-02-06 |
Model Number | 42-2540 |
Catalog Number | 42-2540 |
Lot Number | 247017 |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | COOPERSURGICAL, INC. |
Manufacturer Address | 95 CORPORATE DRIVE TRUMBULL CT 06611 US 06611 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2019-02-06 |